Experience

SEQENS CDMO

• QA Director, QP

  • Sep 2020 - Present

• QA Manager, QP

  • Aug 2018 - Sep 2020



Myllyn Apteekki

• Pharmacist

  • Aug 2016 - Sep 2020

  Part time pharmacist. Part time pharmacist.



Bayer

• Chemical Manufacturing
• 700 & Above Employee

• QA Specialist, QP

  • Jan 2017 - Aug 2018

  Bayer Oy Chemical and Pharmaceutical Development Finland (CPD Fi), Quality Assurance. Acting as QP (Directive 2001/83/EC) for analytical tasks including preclinical and clinical phases as well as marketed products. Providing QA support to the department for QA oversight on e.g. raw material release and supplier management, equipment qualification incl. compliance with current data integrity requirements, analytical method validation, stability studies, change management and deviations.

• Senior Expert, Team Leader

  • 2009 - Dec 2016

  Bayer Oy, CPD Fi, Analytical Development. Responsible for administration and supervision of a laboratory team and for providing analytical support for development projects and submissions. Currently participating in global teams developing drug products at phase III and LCM. Development of the department in named projects. (On study leave for 18 months for pharmacy studies during 2014-2016.)



Bayer Schering Pharma Oy

• Development Manager

  • 2002 - 2008

  Analytical Development. Responsible for administration of lab technicians, 10-25 persons, working in several lab teams. Several development projects covering laboratory infrastructure, IT applications, SOPs, KPI’s, documentation management etc. Active participation in set up of new laboratory facilities. Responsible for giving analytical support in LCM projects such as reviewing analytical documentation of drug products of mainly oral dosage form. Analytical Development. Responsible for administration of lab technicians, 10-25 persons, working in several lab teams. Several development projects covering laboratory infrastructure, IT applications, SOPs, KPI’s, documentation management etc. Active participation in set up of new laboratory facilities. Responsible for giving analytical support in LCM projects such as reviewing analytical documentation of drug products of mainly oral dosage form.



Leiras Oy

• Finland
• Manufacturing

• Scientist/Senior Scientist

  • 1995 - 2002

  Analytical Product Development. Responsible for providing analytical submission documents in re-registration of several domestic marketed products. Participating in manufacturing process validations and cleaning validations. Analytical Product Development. Responsible for providing analytical submission documents in re-registration of several domestic marketed products. Participating in manufacturing process validations and cleaning validations.